Protocol for the TIDAL Melanoma Study: topical imiquimod or diphenylcyclopropenone for the management of cutaneous in-transit melanoma metastases-a phase II, single centre, randomised, pilot study.

INTRODUCTION: Patients with in-transit melanoma metastases present a therapeutic challenge. Complete surgical excision of localised disease is considered as the gold standard; however, surgery is not always acceptable and alternatives are required. Treatment results reported using imiquimod and diphenylcyclopropenone (DPCP) suggest that topical immunotherapies can be used to successfully treat select patients with melanoma metastases. A phase II, randomised, single centre, pilot study was designed to assess the clinical efficacy and safety of DPCP and imiquimod for the treatment of superficial, cutaneous in-transit melanoma metastases. METHODS AND ANALYSIS: This is an open-label, non-superiority, pilot study with no treatment cross-over. Eligible patients are randomised in a 1:1 ratio to receive topical therapy for up to 12 months with a minimum follow-up period of 12 months. The target sample size is 30 patients, with 15 allocated to each treatment arm. The primary endpoint is the number of patients experiencing a complete response of treated lesions as determined clinically using Response Evaluation Criteria in Solid Tumours. This trial incorporates health-related quality of life measures and biological tissue collection for further experimental substudies. The study will also facilitate a health economic analysis. ETHICS AND DISSEMINATION: Approval was obtained from the Human Research Ethics Committee at the participating centre, and recruitment has commenced. The results of this study will be submitted for formal publication within a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Prospectively registered on 16 October 2015 with the Australian New Zealand Clinical Trials Registry (ACTRN12615001088538). This study conforms to WHO Trial Registration Data Set.

Effectiveness and limitations of reflectance confocal microscopy in detecting persistence of basal cell carcinomas: a preliminary study.

BACKGROUND/OBJECTIVES: Reflectance confocal microscopy (RCM) can accurately and non-invasively diagnose basal cell carcinoma (BCC). The use of RCM in assessing responses to saucerization or curettage and cautery of BCC has not been established. The aim of the present study was to expound the usefulness of RCM in assessing treatment responses of BCC to saucerization or curettage and cautery 8-12 weeks after treatment. METHODS: Eight sequential patients, with 11 superficial BCCs, were recruited. Lesions were evaluated clinically and dermoscopically. Three operators performed RCM imaging for each BCC at baseline and 8-12 weeks after treatment. Diagnostic criteria for RCM diagnosis included streaming of basal cells and the presence of cord-like structures and horizontal vessels. Results were compared against histopathology. Difficulties in establishing tumour clearance were identified and the effectiveness of RCM in assessing the response to treatment was explored. RESULTS: At baseline, all lesions were consistent with superficial BCC. At 8-12 weeks after treatment, RCM correctly diagnosed 10 of 11 lesions as tumour free. Furthermore, RCM was reliable across operators of variable experience and the findings were confirmed histopathologically. Limitations were identified, but appeared to be related to operator experience. CONCLUSION: The diagnosis of BCC was straightforward and reliable in the present study. Thus, RCM appears useful in assessing the early treatment response of superficial BCC treated with saucerization or curettage and cautery despite operator-dependent limitations.

Pigmented spindle cell naevus of Reed: a controversial diagnostic entity in Australia.

BACKGROUND/OBJECTIVES: The Reed naevus or pigmented spindle cell naevus of Reed (PSCN) was previously considered a pigmented variant of the spindle cell-type of Spitz naevus. It is now considered a distinct entity and may overlap with cutaneous melanoma in both clinical and dermatoscopic features. We hypothesised that PSCN is an under-recognised entity in Australia and present a typical case. To test our hypothesis, we performed a clinically based survey of Australian dermatology trainees (Registrars). A further aim of our study was to determine the approach of dermatology trainees in this country to the management of this type of lesion. METHODS: A web-based survey questionnaire based on the presented case was circulated to trainees of the Australasian College of Dermatologists. Responses, including level of training and initial approach to management, were collated and form the basis of the results presented herein. RESULTS: Of 39 respondents, 13 (33%) diagnosed the lesion as PSCN. The majority (33/39; 84.6%) indicated they would biopsy the lesion, with most of these (91%) preferring excisional biopsy. CONCLUSIONS: The results support our hypothesis that PSCN is under-recognised in Australia. The results also show that despite difficulty distinguishing this lesion, management of these lesions by dermatology trainees in Australia is consistent and parallels current recommendations.